LCD Reference Article Response To Comments Article

Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease (L38839)

A58671

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Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05101 - MAC A	J - 05	Iowa
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05102 - MAC B	J - 05	Iowa
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05201 - MAC A	J - 05	Kansas
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05202 - MAC B	J - 05	Kansas
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05301 - MAC A	J - 05	Missouri - Entire State
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05302 - MAC B	J - 05	Missouri - Entire State
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05401 - MAC A	J - 05	Nebraska
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05402 - MAC B	J - 05	Nebraska
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05901 - MAC A	J - 05	Alabama Alaska Arizona Arkansas California - Entire State Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi Missouri - Entire State Montana Nebraska Nevada New Hampshire New Jersey New Mexico North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	08101 - MAC A	J - 08	Indiana
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	08102 - MAC B	J - 08	Indiana
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	08201 - MAC A	J - 08	Michigan
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	08202 - MAC B	J - 08	Michigan

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General Information

Article ID
A58671

Article Title
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease (L38839)

Article Type
Response to Comments

Original Effective Date
04/25/2021

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Article Text

This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease (L38839). Noninvasive fractional flow reserve is an alternative modality to gain this information without the need for invasive intracoronary instrumentation in patients with known or suspected coronary artery disease (CAD). This article provides responses to the proposed policy on non-invasive FFR for stable heart disease.
Thank you for the comments.

Response To Comments

Number	Comment	Response
1	Multiple comments were received that CGS should enable FFRct utilization for a wider range of CCTA findings and characteristics. The proposed LCD only allows use of FFRct if a CCTA demonstrates an intermediate coronary stenosis, described as a lumen reduction of 40-70%, in the left anterior descending (LAD), left circumflex (LCX) and right coronary artery (RCA). recommends expansion to 30 to 90% range. Traditionally, patients with greater than 70% stenoses are directed to the cath lab for revascularization. FFR-CT offers an opportunity to personalize each patient’s care plan and reserve invasive therapy for those patients who will specifically benefit. Considering that patients with FFR > 0.80 have been proven to have better clinical outcomes with medical management (regardless of the anatomical stenosis) there is an opportunity to avoid unnecessary invasive procedures even in the 70- 90% stenosis range. The Society of Cardiovascular Computed Tomography (SCCT) proposes that these indications be changed to the following: Left main disease with intermediate coronary stenosis (lumen diameter reduction of 30-50%); OR In vessels other than Left Main, coronary artery disease in any vessel with coronary stenosis of uncertain functional significance (lumen reduction 40-90%)	Thank you for your comments. We respectfully disagree. While we agree that there are multiple clinical studies have demonstrated that patients have better outcomes when revascularization decisions are made based on functional significance (e.g., FFR values) compared to anatomical stenosis alone these studies evaluated invasive FFR and cut-off values that were determined to reduce rates of cardiac death and MI were based on FFR, not FFRct. The concern remains that FFR and FFRCT are not equal. While FFRct’s 80% sensitivity is above comparable modalities it is still suboptimal in comparison to the gold standard of invasive FFR. While FFRct has future potential for reducing the need for invasive coronary angiogram the precise role in this high-risk group has not been fully determined. The reduced PPV of FFRct between 52-65% and the low correlation in the 0.7-0.8 lesions range of 46.1% suggest the correlation between FFRct and invasive FFR in this group is a tenuous 50%. Studies that demonstrate change of management based on FFRct results are challenged by several notable limitations including observational nature with inability to adjust for confounding factors such as additional studies being used to make the ultimate decision of whether or not to proceed with ICA and physician ability to select which arm with overall younger patients with less co-morbidity being triaged to FFRct. There is risk from multiple biases including referral bias, selection bias, attrition bias and other bias, and variable experience with FFRct within the study sites also must be further addressed. Sample size was not large enough to be confident that absence of major adverse events was due to FFRct findings and not chance. Additionally, while major cardiology societies have endorsed the role of FFR there is not endorsement for FFRct for this role in current guidelines to date.
2	Comment from Director of Cardiovascular Imaging and Division Chief of Cardiothoracic Imaging at Cleveland Medical Center. CGS should update their restriction on FFRct utilization in patients with suspected acute coronary syndrome (ACS) to align with the FDA label. SCCT also request removal of suspicion of acute coronary syndrome.	We respectfully disagree. The studies on FFRct are largely limited to the population with stable coronary artery disease. While there is preliminary literature on use in the ACS population this was based on prospective observational data without randomization and duration of follow-up was short term only(Chinnaiyan, Safian et al. 2020). While CTA results can be obtained rapidly since FFRct currently must be sent out and results not immediately available the inability to get real time results of FFRct is a barrier for use in acute situations. In addition, the current FDA label states stable symptomatic patients with CAD removal of this limitation from the FDA-validated filings would be required prior to any reconsideration of use in this population.
3	Comment from Director of Cardiovascular Imaging and Division Chief of Cardiothoracic Imaging at Cleveland Medical Center. CGS should update their restriction on FFRct utilization in patients with an intracoronary metallic stent. SCCT also request removal of intracoronary metallic stents.	The request to remove intracoronary metallic stents was accompanied by a suggested limitation which the manufacture provided as appropriate exclusion in the setting of stents, but without supporting literature. The challenges in reproducible image quality is a known limitation of the technology in the presence of intracoronary stenting. Moreover, the pivotal trials consistently excluded patients with prior percutaneous coronary intervention from participation. Upon review, we find no basis for coverage with the currently available evidence. Incomplete reporting of coronary artery anatomy defeats the purpose of this diagnostic testing therefore does not meet the requirements for payment. Upon availability of evidence to support the efficacy of FFRCT analysis in the presence of intracoronary stents, we can reconsider coverage upon request.
4	Boston Scientific respectfully requests that the restriction of coverage for FFR data obtained by pressure wire at catheterization, should it be performed in addition to FFRct, be removed from the proposed LCD. They cite Driessen et al that only 83% of vessels can be evaluated within demonstrate only 70% accuracy to FFRct leaving a clinical need for FFR obtained by pressure wire even after FFRct in some cases. Philips comments are focused on the proposed LCD’s coverage limitation that Medicare will not pay for both FFRct and FFR obtained by pressure wiring catheterization in the context the same clinical evaluation, or onset of new symptom complex. Philips opposes this limitation for the following reasons and urges CGS to remove the limitation in any final policy. SCCT request removal of the language prohibiting payment of both FFRct and invasive FFR used in the same episode of care. The ACC recommends the restriction of coverage for FFR data obtained by pressure wire at catheterization, should it be performed in addition to FFRct, be removed from the LCD.	Thank you for your comments we agree, and this has been removed from the policy. We recognize that FFRct is a valuable tool but does not have equivalency of invasive FFR. We understand there are rare but notable circumstances where the FFRct may not be accurate and confirmation with invasive FFR is needed. In addition, there are false positives FFRct cases in which case invasive FFR may prevent unnecessary stenting, or to assess for residual ischemia after stenting.
5	CAC member: I would suggest re-considering would be in the patient with known triple-vessel CAD as well as in the evaluation of saphenous vein bypass grafts. First, in patients with known triple-vessel CAD, selective vessel FFR can help determine physiologic significance and whether a patient really needs coronary artery bypass graft surgery or can be treated safely by PCI or even medical therapy until disease progresses. For patients with prior bypass grafts, I personally feel that CCTA with FFR can be very valuable in these patients, as sometimes bypass grafts can be hard to find and cannulate during coronary angiography, whereas noninvasive CCTA combined with FFR may be valuable in these patients	We understand the potential clinical value of a non-invasive technology in a setting where invasive measures represent a potential higher risk to the patient. However, this was not accompanied by supporting literature of use in this population and the pivotal studies excluded these patients. It is unclear if the greater risk they inherently have due to their underlying cardiovascular disease can impact the accuracy or interpretation in this group since it was not studied. If additional literature provides support for inclusion of this group, it can be re-evaluated through reconsideration.
6	CAC member: the exclusion of obese patients with BMI > 35 is interesting because, while CCTA image quality may be suboptimal in these patients, these are the patients in whom stress echocardiography may also be of poor image quality and in whom nuclear stress testing not infrequently is either inconclusive/nondiagnostic or false-positive due to breast and diaphragmatic attenuation, so I personally believe that CCTA with FFR may also be valuable in these patients. ACC and SCCT recommends removal of severe obesity.	Thank you for your comment. Numerous, pivotal trials repeatedly exclude patients with this BMI criteria and even those that included trial participants with elevated BMI, no study has included enough patients to show that the technology performs similarly beyond BMI of 35kg/m2. Based on the results of the ADVANCE study this criterion was expanded from 35 to 39kg/m2 but supporting evidence to expand beyond this level was not provided. While evidence exists for CCTA in obese patients, this simply has not been shown for FFRCT. We can reconsider this limitation upon receiving high-quality, patient-oriented evidence that prove FFRCT in obese patient populations have results similar in validity and accuracy to those patients that are less than 35kg/m2. Formal removal of this FDA-validated limitation would be necessary for a successful reconsideration of this policy. The limitation will remain as written.
7	ACC recommends removal of prosthetic valves and pacemakers/defibrillators.	Strict adherence to careful patient selection contributed significantly to demonstrating the net health benefit for FFRct. No supporting research was submitted to support removal of prosthetic value, or pacemakers. Pivotal trials for FFRCT consistently excluded patient populations with prosthetic valves and pacemakers from study. Furthermore, these limitations are reported by the manufacturer in FDA filings. Due to the unavailability of U.S.-based, high-quality, peer-reviewed published clinical research in this patient populations we must conclude that it is still investigational and therefore unreasonable to consider for coverage at this time. Upon availability of this evidence, as well as removal of this limitation from the FDA-validated filings, we can reconsider this coverage limitation upon request. The limitation will remain as written.
8	SCCT recommends removal of limitation of severe aortic stenosis and ACC request removal of newly diagnosed systolic heart failure, with no prior left heart catheterization	There was not literature submitted to support the removal of this limitation and provide evidence for use in this population and the pivotal studies excluded these patients. It is unclear if the greater risk they inherently have due to their underlying cardiac disease can impact the accuracy or interpretation of FFRct. If additional peer-reviewed published literature provides support for inclusion of this group, it can be re-evaluated through reconsideration. Associated Documents Chinnaiyan, K. M., R. D. Safian, M. L. Gallagher, J. George, S. R. Dixon, A. N. Bilolikar, A. E. Abbas, M. Shoukfeh, M. Brodsky and J. Stewart (2020). "Clinical use of CT-derived fractional flow reserve in the emergency department." JACC: Cardiovascular Imaging 13(2): 452-461.

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Contents

Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease (L38839)

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Response To Comments

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